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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device controls for blood-gases, (assayed and unassayed)
Regulation Description Quality control material (assayed and unassayed).
Product CodeJJS
Regulation Number 862.1660
Device Class 1


Premarket Reviews
ManufacturerDecision
BIONOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 9
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 3
MARQUEST MEDICAL PRODUCTS INC
  SUBSTANTIALLY EQUIVALENT 1
NOVA
  SUBSTANTIALLY EQUIVALENT 1
  1.  K952477  STAT PROFILE ULTRA BLOOD GAS CONTROLS
RADIOMETER
  SUBSTANTIALLY EQUIVALENT 3

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